FDA Approves First COVID-19 Vaccine
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The USFDA gave full approval to Pfizer’s Covid-19 vaccine on Aug 23, a milestone that may help lift public confidence in the shots as the nation battles the highly contagious Delta variant. Over 200 million Pfizer doses already have been administered in the US — and hundreds of millions more worldwide — since emergency use began in December.

“The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” said acting FDA commissioner Janet Woodcock. The US becomes the first country to fully approve the shot, according to Pfizer, and CEO Albert Bourla said he hoped the move “will help increase confidence in our vaccine”. The action also may spur more vaccine mandates by firms, universities and local governments.

The FDA, like regulators in Europe and much of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people 16 and older for at least two months. That’s shorter than the six months of safety data normally required for full approval. So Pfizer kept that study going, and the FDA also examined real-world safety evidence in deciding to fully license the vaccine for people 16 and older, those studied the longest. Pfizer shot still has emergency approval for 12- to 15-year-olds.